1. DUNS issues: Several people have started setting up drug listing for their products. There are several fundamental issues with gathering information for the drug listing. The biggest issue has been the DUNS number. Information has been inaccurate and correcting this information has been a challenge. Many of the issues are specific to the establishments, so we see no need for a meeting with D&B and each organization should arrange to speak to a D&B representative. Some of the issues include the following:
Obtaining new DUNS numbers after an acquisition rather than updating the information to inherit the DUNS number. The old DUNS number is not deleted, so many of the numbers are no longer in use.
Names and addresses to not match exactly. We are not sure what the link is between the DUNS number U.S. Customs uses and FDA. Do these numbers have to be identical? Is there a way to know which number U.S. Customs uses.
2. Workgroup Training session with FDA
The ER/DL workgroup would like to set up a training with FDA to walk through a sample drug listing and be available for questions. Since most people in the group have had an opportunity to look at the new SPL r.4, the session can be more fruitful. The training session will occur either October 8th at 1:00 pm ET or October 15th at the same time. This session will take over the time of the meeting session it falls on (ER/DL Workgroup or SPL Process Team)
As a reminder, FDA is still open for those who would like to participate in a one-on-one training session. A webinar will be set up between the organization and FDA and will walk through a live submission to find any kinks along the way. Case Studies will be created based on these sessions (sponsors can change the information to keep it confidential) and these will be posted on the WIKI for informational purposes. Any volunteers can contact either me or spl@fda.hhs.gov. A few individuals have already contacted FDA to set up a meeting.
3. Establishment Questions
There have been a few questions about establishments listing in SPL. If manufacturers are supposed to list their products, what happens to the distributor's NDC number (is it lost)? The process will actually be similar to the current process so the NDC numbers should really not change. The labeler will be the company that owns the NDC code and the registrant can be a labeler or manufacturer. Since the SPL will most likely be generated by the company that controls the marketing application, this is most likely the labeler and the company that controls the NDC number. There are also Private Label Distributors that submit on behalf of the company, so this is another scenario.
Establishment registrations will be completed in one overall SPL file. Some companies had difficulties with this because they have different divisions within their company. Additionally, some have completely different functions, i.e., Rx, OTC and Vet Meds. These divisions operate under one corporate umbrella but are completely independent of each other and do not exchange company information.
4. Next meeting will be on October 8, 2008 at 1 pm EDST.
1. DUNS issues:
Several people have started setting up drug listing for their products. There are several fundamental issues with gathering information for the drug listing. The biggest issue has been the DUNS number. Information has been inaccurate and correcting this information has been a challenge. Many of the issues are specific to the establishments, so we see no need for a meeting with D&B and each organization should arrange to speak to a D&B representative. Some of the issues include the following:
Obtaining new DUNS numbers after an acquisition rather than updating the information to inherit the DUNS number. The old DUNS number is not deleted, so many of the numbers are no longer in use.
Names and addresses to not match exactly. We are not sure what the link is between the DUNS number U.S. Customs uses and FDA. Do these numbers have to be identical? Is there a way to know which number U.S. Customs uses.
2. Workgroup Training session with FDA
The ER/DL workgroup would like to set up a training with FDA to walk through a sample drug listing and be available for questions. Since most people in the group have had an opportunity to look at the new SPL r.4, the session can be more fruitful. The training session will occur either October 8th at 1:00 pm ET or October 15th at the same time. This session will take over the time of the meeting session it falls on (ER/DL Workgroup or SPL Process Team)
As a reminder, FDA is still open for those who would like to participate in a one-on-one training session. A webinar will be set up between the organization and FDA and will walk through a live submission to find any kinks along the way. Case Studies will be created based on these sessions (sponsors can change the information to keep it confidential) and these will be posted on the WIKI for informational purposes. Any volunteers can contact either me or spl@fda.hhs.gov. A few individuals have already contacted FDA to set up a meeting.
3. Establishment Questions
There have been a few questions about establishments listing in SPL. If manufacturers are supposed to list their products, what happens to the distributor's NDC number (is it lost)? The process will actually be similar to the current process so the NDC numbers should really not change. The labeler will be the company that owns the NDC code and the registrant can be a labeler or manufacturer. Since the SPL will most likely be generated by the company that controls the marketing application, this is most likely the labeler and the company that controls the NDC number. There are also Private Label Distributors that submit on behalf of the company, so this is another scenario.
Establishment registrations will be completed in one overall SPL file. Some companies had difficulties with this because they have different divisions within their company. Additionally, some have completely different functions, i.e., Rx, OTC and Vet Meds. These divisions operate under one corporate umbrella but are completely independent of each other and do not exchange company information.
4. Next meeting will be on October 8, 2008 at 1 pm EDST.